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Study of Collagen Efficacy on Skin Anti-aging in 30 to 50-Year-Old Women

Primary Purpose

Skin Laxity, Skin Fold

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
WonderLab Collagen Tripeptide Drink
Ordinary Drink
Sponsored by
Shenzhen Precision Health Food Technology Co. Ltd.,
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Skin Laxity focused on measuring Collagen, skin hydration, skin elasticity, anti-aging

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Chinese females, age between 30-50; Be in general good health; Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate; Have mild to moderate darker skin tone 3 on Unilever visual scale of 1~9; Have mild pigmentation level 2 on Unilever visual scale of 0~9; Have visual grading score on crow's feet 3 on Unilever visual scale of 0~9; Have visual grading score on peri-oral 3 on Unilever visual scale of 0~9; Have visual grading score on nasolabial folds 3 on Unilever visual scale of 0~9; Tolerate to well-known anti-aging actives; Agree to not use any other creams, lotions, moisturizers on the face, other than what is provided for the duration of the study; Agree to refrain from wearing make-up (such as foundation, eye shadow, lipstick etc.) or any skin care products on the face on the study visits; Agree to avoid washing the treatment site area for two hours following product application and agree to avoid washing appliances (i.e., sponge, wash cloth, loofah, etc.). Exclusion Criteria: Have used any skin lightening /anti-aging benefits products at least one month before this study Subject having done facial injections and/or aesthetic surgery. Be involved in any aspect of test administration, i.e., evaluating or overseeing activities related to product. Have participated in any clinical study involving the test sites within the previous 6 months, or is subject participating in any clinical study concurrently. Have a history of any type of bottlecer, including but not limited to any type of skin bottlecer (squamous or basal cell carcinoma at the treatment site) or history of malignant melanoma at any body site. Have a history of skin disease or the presence of a skin condition on the test sites that the Investigator feels would interfere with the study. Be taking antihistamines (> 3x/week) or anti-inflammatory (> 8x/week) on a regular basis, or has the subject taken systemic or topical steroidal medications within 4 weeks of study enrolment. Have any of the following conditions or factors that the investigator believes may affect the response of the skin or the interpretation of the test results, including, but not limited to, diabetes, pregnancy, lactation. Have any cuts/abrasions on the test site at baseline. Have had a suspicious skin lesion removed by a dermatologist at any time. The subject is an employee of sponsor or the site conducting the study.

Sites / Locations

  • Ai'er Hospital
  • SPRIM Central Lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

WonderLab Collagen Tripeptide Drink

Ordinary Drink

Arm Description

25ml/bottle, containing the following ingredients per 25ml serving: Collagen 6000 mg Vitamins C 250 mg Hyaluronic acid 50 mg Nicotinamide 0.45 mg

25ml/bottle, containing the following ingredients per 25ml serving: Peach juice 8 mg Erythritol 10 mg

Outcomes

Primary Outcome Measures

Skin Elasticity
The changes of skin elasticity by CK Cutometer MPA580
Skin Moisture
The changes of skin moisture by Corneometer CM 825

Secondary Outcome Measures

Skin Barrier
The changes of skin barrier in terms of TEWL (Trans Epidermal Water Loss) by Aquaflux F200
Lines/Wrinkles
The changes of the lines/wrinkles on the face by Miravex Antera 3D imaging system
Skin Diagnosis
The skin diagnosis (4 modes and 2 side views) with VISIA CR Facial Imaging System

Full Information

First Posted
December 26, 2022
Last Updated
April 10, 2023
Sponsor
Shenzhen Precision Health Food Technology Co. Ltd.,
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1. Study Identification

Unique Protocol Identification Number
NCT05682092
Brief Title
Study of Collagen Efficacy on Skin Anti-aging in 30 to 50-Year-Old Women
Official Title
A Randomized Double-blind Controlled Study of Collagen Efficacy on Skin Anti-aging in 30 to 50-Year-Old Women
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
March 12, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Precision Health Food Technology Co. Ltd.,

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This goal of this clinical trial is to study the efficacy of collagen supplement on skin moisture and elasticity in middle-aged women of 30-50 years old. Participants will be assigned two products with and without collagen supplement and use for 2 months, twice a day. Researchers will compare the two groups whether there are siginificant improvement of skin moisture and elasticity for participants via skin measurement and anaysis system.
Detailed Description
This is a two arms, randomized, double-blind controlled trial. Study product plus collagen supplement and placebo product but without collagen will be randomly assigned to 70 eligible participants who will be enrolled at two study sites in Shanghai. Participants need to use the assigned product one bottle (25ml) each time, twice a day and visit the study site for three times (baseline day, day 30 and day 60) during the 2-month study. For each visit, the primary outcomes (skin hydration and skin elasticity) and secondary outcomes (skin barrier, lines/wrinkles, and facial glow,etc.) will be measured with professional equiment and imaging system and recorded to data management system. At the end of the study, the study data will exported and analyzed to validate the assumption that the collagen could improve skin moisture content and elasticity in middle-aged women of 30-50 years old.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity, Skin Fold
Keywords
Collagen, skin hydration, skin elasticity, anti-aging

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WonderLab Collagen Tripeptide Drink
Arm Type
Active Comparator
Arm Description
25ml/bottle, containing the following ingredients per 25ml serving: Collagen 6000 mg Vitamins C 250 mg Hyaluronic acid 50 mg Nicotinamide 0.45 mg
Arm Title
Ordinary Drink
Arm Type
Placebo Comparator
Arm Description
25ml/bottle, containing the following ingredients per 25ml serving: Peach juice 8 mg Erythritol 10 mg
Intervention Type
Dietary Supplement
Intervention Name(s)
WonderLab Collagen Tripeptide Drink
Intervention Description
the participant in this arm will use the assigned product 25ml one time, twice a day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ordinary Drink
Intervention Description
the participant in this arm will use the assigned product 25ml one time, twice a day.
Primary Outcome Measure Information:
Title
Skin Elasticity
Description
The changes of skin elasticity by CK Cutometer MPA580
Time Frame
baseline day 0, day 30, day 60
Title
Skin Moisture
Description
The changes of skin moisture by Corneometer CM 825
Time Frame
baseline day 0, day 30, day 60
Secondary Outcome Measure Information:
Title
Skin Barrier
Description
The changes of skin barrier in terms of TEWL (Trans Epidermal Water Loss) by Aquaflux F200
Time Frame
baseline day 0, day 30, day 60
Title
Lines/Wrinkles
Description
The changes of the lines/wrinkles on the face by Miravex Antera 3D imaging system
Time Frame
baseline day 0, day 30, day 60
Title
Skin Diagnosis
Description
The skin diagnosis (4 modes and 2 side views) with VISIA CR Facial Imaging System
Time Frame
baseline day 0, day 30, day 60

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
the participants must be middle-aged women of 30-50 years old
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Chinese females, age between 30-50; Be in general good health; Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate; Have mild to moderate darker skin tone 3 on Unilever visual scale of 1~9; Have mild pigmentation level 2 on Unilever visual scale of 0~9; Have visual grading score on crow's feet 3 on Unilever visual scale of 0~9; Have visual grading score on peri-oral 3 on Unilever visual scale of 0~9; Have visual grading score on nasolabial folds 3 on Unilever visual scale of 0~9; Tolerate to well-known anti-aging actives; Agree to not use any other creams, lotions, moisturizers on the face, other than what is provided for the duration of the study; Agree to refrain from wearing make-up (such as foundation, eye shadow, lipstick etc.) or any skin care products on the face on the study visits; Agree to avoid washing the treatment site area for two hours following product application and agree to avoid washing appliances (i.e., sponge, wash cloth, loofah, etc.). Exclusion Criteria: Have used any skin lightening /anti-aging benefits products at least one month before this study Subject having done facial injections and/or aesthetic surgery. Be involved in any aspect of test administration, i.e., evaluating or overseeing activities related to product. Have participated in any clinical study involving the test sites within the previous 6 months, or is subject participating in any clinical study concurrently. Have a history of any type of bottlecer, including but not limited to any type of skin bottlecer (squamous or basal cell carcinoma at the treatment site) or history of malignant melanoma at any body site. Have a history of skin disease or the presence of a skin condition on the test sites that the Investigator feels would interfere with the study. Be taking antihistamines (> 3x/week) or anti-inflammatory (> 8x/week) on a regular basis, or has the subject taken systemic or topical steroidal medications within 4 weeks of study enrolment. Have any of the following conditions or factors that the investigator believes may affect the response of the skin or the interpretation of the test results, including, but not limited to, diabetes, pregnancy, lactation. Have any cuts/abrasions on the test site at baseline. Have had a suspicious skin lesion removed by a dermatologist at any time. The subject is an employee of sponsor or the site conducting the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun Wang, MD
Organizational Affiliation
NO. 9 Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ai'er Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
SPRIM Central Lab
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24401291
Citation
Proksch E, Schunck M, Zague V, Segger D, Degwert J, Oesser S. Oral intake of specific bioactive collagen peptides reduces skin wrinkles and increases dermal matrix synthesis. Skin Pharmacol Physiol. 2014;27(3):113-9. doi: 10.1159/000355523. Epub 2013 Dec 24.
Results Reference
background
PubMed Identifier
21480801
Citation
Zague V, de Freitas V, da Costa Rosa M, de Castro GA, Jaeger RG, Machado-Santelli GM. Collagen hydrolysate intake increases skin collagen expression and suppresses matrix metalloproteinase 2 activity. J Med Food. 2011 Jun;14(6):618-24. doi: 10.1089/jmf.2010.0085. Epub 2011 Apr 11.
Results Reference
background
PubMed Identifier
23949208
Citation
Proksch E, Segger D, Degwert J, Schunck M, Zague V, Oesser S. Oral supplementation of specific collagen peptides has beneficial effects on human skin physiology: a double-blind, placebo-controlled study. Skin Pharmacol Physiol. 2014;27(1):47-55. doi: 10.1159/000351376. Epub 2013 Aug 14.
Results Reference
background
PubMed Identifier
16154324
Citation
Nouveau-Richard S, Yang Z, Mac-Mary S, Li L, Bastien P, Tardy I, Bouillon C, Humbert P, de Lacharriere O. Skin ageing: a comparison between Chinese and European populations. A pilot study. J Dermatol Sci. 2005 Dec;40(3):187-93. doi: 10.1016/j.jdermsci.2005.06.006. Epub 2005 Sep 8.
Results Reference
background
PubMed Identifier
21535500
Citation
Liang J, Pei X, Zhang Z, Wang N, Wang J, Li Y. The protective effects of long-term oral administration of marine collagen hydrolysate from chum salmon on collagen matrix homeostasis in the chronological aged skin of Sprague-Dawley male rats. J Food Sci. 2010 Oct;75(8):H230-8. doi: 10.1111/j.1750-3841.2010.01782.x. Epub 2010 Sep 24.
Results Reference
background

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Study of Collagen Efficacy on Skin Anti-aging in 30 to 50-Year-Old Women

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